Failed Eylea combo trial throws a wrench in Regeneron's expansion effort


Regeneron is looking for ways to keep star med Eylea growing well into the future--and pacing ahead of the competition. But it looks like a combination with compound rinucumab won’t be one of them.

Friday, the Tarrytown, NY-based drugmaker announced that the tandem failed to outperform solo Eylea at treating wet age-related macular degeneration in a Phase IIb trial. In fact, the duo did worse than Eylea itself, coming up inferior to monotherapy.

While management had “tempered” expectations for the pairing, “the lack of any benefit relative to Eylea in the combo arms is a surprise,” Evercore ISI analyst John Scotti wrote in a note to clients. The lack of dose response--both at 1 mg and 3 mg of rinucumab--also raised some eyebrows, he noted.

And that wasn’t all. At the 12-week primary endpoint, the coformulation had produced a higher rate of adverse events--including conjunctival hemorrhage and eye pain--than Eylea had, too.

Eylea isn’t exactly used to failing. The med has racked up indications in macular edema and diabetic retinopathy since winning its original wet AMD nod, cruising to blockbuster status in the meantime. In Q2, it scored $831 million in U.S. sales, keeping numbers in line with Regeneron’s Eylea guidance of 20% to 25% expansion for the year.

And the product has come up big for overseas partner Bayer, too, which last week said it now expects peak sales for the drug to reach at least €2.5 billion--an improvement on the €1.5 billion execs initially forecast.

Now, though, Scotti pointed out, all eyes will be on a different Eylea combo trial--a Phase II study pairing the therapy with nesvacumab, which began earlier this year.

While the failure of the rinucumab Eylea extension “strikes a blow to the lifecycle management of Regeneron’s key product, the company still retains one shot on goal,” with the nesvacumab pairing, Leerink Partners analyst Geoffrey Porges agreed in his own investor note.

- read the release 

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